Actively Recruiting
A First-in-human, Open-label Trial to Evaluate ACTengine® IMA203 Combined With mRNA-4203 in Previously Treated Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma
Led by Immatics US, Inc. · Updated on 2026-01-08
15
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Immatics US, Inc.
Lead Sponsor
M
ModernaTX, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and anti-tumor activity of a combination treatment involving IMA203 and different doses of mRNA-4203. This trial focuses on adults with previously treated unresectable or metastatic cutaneous melanoma or synovial sarcoma who are HLA-A*02:01 positive. The study is a multi-center, open-label, non-comparative Phase 1 a/b trial to assess these treatments in this specific patient group. Participants receive non-myeloablative chemotherapy with fludarabine and cyclophosphamide for lymphodepletion, followed by a single infusion of IMA203 on Day 1. Low dose interleukin-2 is given for up to 10 days starting about 24 hours after the IMA203 infusion. mRNA-4203 treatment begins no earlier than Day 15 after the IMA203 infusion and is administered in 12 cycles over 28 days each, with doses given on Days 1 and 15 in Cycle 1 and Day 1 for Cycles 2 through 12. The trial involves different cohorts exploring this combination. During the study, participants undergo monitoring for dose-limiting toxicities, treatment-emergent adverse events, laboratory changes, and vital signs for up to one year after IMA203 infusion. Researchers will assess tumor response rates, duration of response, disease control, progression-free survival, and the concentration of the IMA203 transgene in the blood. The study includes safety follow-up and ongoing evaluation of treatment impact over a one-year period after infusion.
CONDITIONS
Brief Title
ACTengine® IMA203 Combined With mRNA-4203
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed unresectable or metastatic cutaneous melanoma or synovial sarcoma
- Positive for HLA-A*02:01
- Adequate organ function as defined in the protocol
- ECOG performance status of 0 or 1
- Measurable disease by RECIST 1.1 criteria
- Life expectancy longer than 5 months
- For cutaneous melanoma: disease progression after at least one PD-1 inhibitor treatment
- For synovial sarcoma: received or declined at least one prior systemic therapy and still need further treatment
- Female participants of childbearing potential must use effective contraception until 12 months after IMA203 infusion and 15 days after last mRNA-4203 dose
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- History of other cancers within the last 3 years except treated basal or squamous cell carcinoma or carcinoma in situ
- Pregnant or breastfeeding
- Serious autoimmune diseases
- Specific cardiac conditions as per protocol
- Prior allogenic stem cell or solid organ transplantation
- Severe uncontrolled medical diseases that interfere with study participation
- Allergies to cyclophosphamide, fludarabine, IL-2, or mRNA-based medicines
- Positive HIV or active hepatitis B or C infection
- Conditions preventing leukapheresis
- Elevated lactate dehydrogenase above protocol limits
- Active brain metastases before lymphodepletion
- Concurrent participation in other clinical or device trials interfering with IMA203
- Renal impairment with reduced bone marrow reserve as per protocol
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 months (12 cycles of 28 days each for mRNA-4203 plus initial lymphodepletion and IMA203 infusion period)
Participants receive non-myeloablative chemotherapy for lymphodepletion followed by a single infusion of IMA203 and adjunctive low dose interleukin-2 for up to 10 days. Starting on Day 15 after IMA203 infusion, participants receive mRNA-4203 for 12 cycles with treatments on Day 1 and Day 15 of Cycle 1, and Day 1 of Cycles 2 through 12.
Multiple visits during initial 10 days post IMA203 infusion and scheduled visits every 2 weeks during Cycle 1, then every 4 weeks for Cycles 2 to 12
Duration - Up to 1 year post IMA203 infusion
Participants are monitored for safety, treatment emergent adverse events, and anti-tumor activity for up to one year after IMA203 infusion.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 4 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Immatics US, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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